A Study of Nivolumab or Nivolumab Plus Experimental Medic... | NCT03519256

NCT03519256

ID	Type	Description	Link
2017-003581-27	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Nivolumab monotherapy	Experimental	Biological: Nivolumab
Nivolumab + BCG	Experimental	Biological: Nivolumab Biological: BCG
Nivolumab + BMS-986205	Experimental	Biological: Nivolumab Drug: BMS-986205
Nivolumab + BMS-986205 + BCG	Experimental	Biological: Nivolumab Biological: BCG Drug: BMS-986205

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Nivolumab + BCG Nivolumab + BMS-986205 Nivolumab + BMS-986205 + BCG Nivolumab monotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Number of Participants With Serious Adverse Events (SAEs)	Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) Requires inpatient hospitalization or causes prolongation of existing hospitalization. SAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs leading to discontinuation are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0044		Los Angeles	California	90033	United States
Local Institution - 0081

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
FG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 22, 2021

Arm/Group Information

ID	Title	Description
BG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
BG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
BG002	Arm C: Nivolumab Plus BMS-986205	Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
BG003	Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00061.8± 11.1 BG00169.0± 9.4 BG00269.1± 12.3 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0014 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0012 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00013 BG00126 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events (AEs)

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

All randomized participants who received at least one dose of any study medication.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
OG002	Arm C: Nivolumab Plus BMS-986205	Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
OG003	Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.

Units	Counts
Participants	OG00016 OG00126 OG00217 OG003

Title

Denominators

Categories

Title	Measurements
	OG00015 OG00126 OG00215 OG003

Primary

Number of Participants With Serious Adverse Events (SAEs)

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:

Results in death
Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
Requires inpatient hospitalization or causes prolongation of existing hospitalization.

SAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

All randomized participants who received at least one dose of any study medication.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
OG002	Arm C: Nivolumab Plus BMS-986205

Primary

Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs leading to discontinuation are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

All randomized participants who received at least one dose of any study medication.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.

Primary

Number of Participants Immune-Mediated Adverse Events (IMAEs)

IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity IMAEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

All randomized participants who received at least one dose of any study medication.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
OG002	Arm C: Nivolumab Plus BMS-986205	Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).

Primary

Number of Participants Who Died

Number of participants who died.

All randomized participants who received at least one dose of any study medication.

Posted

Count of Participants

Participants

From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
OG002	Arm C: Nivolumab Plus BMS-986205	Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).
OG003	Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG

Primary

Number of Participants With Specific Liver Laboratory Abnormalities

On-treatment laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment.

ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal.

All randomized participants who received at least one dose of any study medication and had at least one on-treatment liver laboratory measurement.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
OG002	Arm C: Nivolumab Plus BMS-986205

Primary

Number of Participants With Specific Thyroid Laboratory Abnormalities

TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal

All randomized participants who received at least one dose of any study medication and had at least one on-treatment thyroid laboratory measurement.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
OG002	Arm C: Nivolumab Plus BMS-986205

Primary

Number of Participants With Changes From Baseline Laboratory Values

On-study laboratory parameters include hematology, chemistry, liver function, and renal function. On-study laboratory evaluations are evaluations taken after the day (and time, if collected and not missing) of first dose of study treatment. For participants who are off study treatment, evaluations were within a safety window of 30 days after the last dose of study treatment. On-study lab parameters are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

All randomized participants who received at least one dose of any study medication and had at least one on-study select laboratory measurement.

Posted

Count of Participants

Participants

From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.
OG002

Primary

Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status

An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug.

An ADA-positive participant has at least one ADA positive-sample relative to baseline at any time after initiation of treatment An ADA-negative participant doesn't not have an ADA-positive sample after the initiation of treatment.

All randomized participants who received at least one dose of any study medication and had evaluable ADA status.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.

Primary

Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:

Results in death
Is life-threatening (an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
Requires inpatient hospitalization or causes prolongation of existing hospitalization.

An Anti-drug antibody (ADA) is defined as biologic drug-reactive antibody, including pre-existing host antibodies that are cross-reactive with the administered biologic drug.

All randomized participants who received at least one dose of any study medication and had evaluable ADA status.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)

ID	Title	Description
OG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).
OG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Nivolumab	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months).	0	16	4	16	15	16
EG001	Arm B: Nivolumab Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks (12 months) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months and 12 months following the first intravesical dose.	3	26	7	26	26	26
EG002	Arm C: Nivolumab Plus BMS-986205	Nivolumab 480 mg IV every 4 weeks (Q4W) and 100 mg oral BMS-986205 daily for up to 52 weeks (12 months).	2	17	7	17	15	17
EG003	Arm D: Nivolumab Plus BMS-986205 Plus Intravesical BCG	Nivolumab 480 mg IV every 4 weeks (Q4W), 100 mg oral BMS-986205 daily for up to 52 weeks (12 months), and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3 months, 6 months, and 12 months following the first intravesical dose.	0	10	5	10	10	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ventricular arrhythmia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG0030 affected10 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Death	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Disease recurrence	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Post procedural sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Wound infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0003 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Hypotension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0003 affected16 at risk EG0010 affected26 at risk EG0022 affected17 at risk EG0031 affected10 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Palpitations	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Glucocorticoid deficiency	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0013 affected26 at risk EG0022 affected17 at risk EG003
Diplopia	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Metamorphopsia	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Vision blurred	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0020 affected17 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 affected16 at risk EG0012 affected26 at risk EG0023 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 affected16 at risk EG0014 affected26 at risk EG0024 affected17 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0013 affected26 at risk EG0020 affected17 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 affected16 at risk EG0013 affected26 at risk EG0022 affected17 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0022 affected17 at risk EG003
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0022 affected17 at risk EG003
Chills	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0003 affected16 at risk EG0019 affected26 at risk EG0023 affected17 at risk EG003
Gait disturbance	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Influenza like illness	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Localised oedema	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0021 affected17 at risk EG003
Pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Thirst	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0022 affected17 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Bacterial disease carrier	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Candida infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Cystitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0020 affected17 at risk EG003
Device related infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Ear infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Groin infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Nail infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Orchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Oropharyngeal candidiasis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0022 affected17 at risk EG003
Sinusitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Tooth infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0019 affected26 at risk EG0022 affected17 at risk EG003
Wound infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0002 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Stoma site hypergranulation	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Vascular access site rash	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0012 affected26 at risk EG0024 affected17 at risk EG003
Amylase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Antinuclear antibody positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0025 affected17 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Blood methaemoglobin present	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0002 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Blood uric acid increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Blood urine present	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Carbohydrate antigen 19-9 increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Heart rate irregular	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
International normalised ratio increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Lipase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Neutrophil count increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Neutrophil percentage increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
PCO2 increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Transaminases increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Weight decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0002 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0005 affected16 at risk EG0011 affected26 at risk EG0022 affected17 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0020 affected17 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0012 affected26 at risk EG0020 affected17 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0003 affected16 at risk EG0012 affected26 at risk EG0021 affected17 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0002 affected16 at risk EG0010 affected26 at risk EG0022 affected17 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Polydipsia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0016 affected26 at risk EG0021 affected17 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0015 affected26 at risk EG0022 affected17 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0015 affected26 at risk EG0020 affected17 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0012 affected26 at risk EG0021 affected17 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Amnesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0013 affected26 at risk EG0021 affected17 at risk EG003
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Syncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0022 affected17 at risk EG003
Persistent depressive disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0013 affected26 at risk EG0020 affected17 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG00110 affected26 at risk EG0021 affected17 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0004 affected16 at risk EG00111 affected26 at risk EG0024 affected17 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0017 affected26 at risk EG0020 affected17 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0002 affected16 at risk EG0018 affected26 at risk EG0021 affected17 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Strangury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0020 affected17 at risk EG003
Urethral pain	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0013 affected26 at risk EG0021 affected17 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Urinary tract pain	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Ejaculation disorder	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Penile pain	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0020 affected17 at risk EG003
Testicular mass	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0014 affected26 at risk EG0021 affected17 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0020 affected17 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0021 affected17 at risk EG003
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0003 affected16 at risk EG0016 affected26 at risk EG0023 affected17 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0013 affected26 at risk EG0021 affected17 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0012 affected26 at risk EG0021 affected17 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Flushing	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0020 affected17 at risk EG003
Hypotension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0011 affected26 at risk EG0021 affected17 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected16 at risk EG0010 affected26 at risk EG0020 affected17 at risk EG003

Certain Agreements

ID	Term
D001749	Urinary Bladder Neoplasms
D000093284	Non-Muscle Invasive Bladder Neoplasms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins